Request to Conduct Research for Same Use of Stored Human Samples, Specimens, or Data Collected in a Terminated NCI-IRB Protocol

Trial Information

Request to Conduct Research for Same Use of Stored Human Samples, Specimens, or Data Collected in a Terminated NCI-IRB Protocol

OBJECTIVES:

- Conduct research for same use of stored human samples, specimens, and data collected
from patients previously enrolled in a terminated National Cancer
Institute-Institutional Review Board clinical trial.

- Correlate plasma levels and pharmacokinetics with disease burden and presence of
antibodies.

- Correlate tumor markers with disease burden.

- Determine the utility of tumor markers for following patients after treatment.

OUTLINE: Stored human samples, specimens, and data collected from patients previously
enrolled in a terminated National Cancer Institute-Institutional Review Board clinical trial
are analyzed for research studies*. Antibodies are neutralized to allow for correlation of
ELISA assays for immunogenicity with neutralization assays, which require cytotoxicity
assays. In cytotoxicity assays, fresh malignant cells are isolated from blood, bone marrow,
lymph nodes, or other tissues and incubated with recombinant immunotoxins to determine their
sensitivity. Soluble CD25 assays are used to analyze known marker for B-cell malignancies,
particularly those that are CD25-positive. Other candidate tumor markers include soluble
IRTA2, soluble CD22, and soluble mesothelin. Skin biopsies retained by the Clinical
Pathology Lab are used to study capillary leak syndrome. Other research studies include HLA
typing to correlate immunological parameters with response and the PAX-gene tube to obtain
RNA for quantitative PCR, evaluate monoclonal immunoglobulin expression, study minimal
residual disease, and characterize immunoglobulin gene usage and somatic mutation. RNA
microarrays are used to study resistance to immunotoxins. Samples of blood are used to study
mechanisms of hemolytic uremic syndrome (HUS) from anti-CD22 immunotoxins. DNA samples are
analyzed for complement and/or Factor H mutations that would make a patient more susceptible
to HUS. Samples are also analyzed for levels of immunotoxin in blood, urine, and other
tissues and for quantification of tumor markers on malignant cells using flow cytometry
assays.

NOTE: *Assays that have significant risk to the patient or to the patient's family,
including genetic cancer susceptibility studies, will not be performed.

Inclusion Criteria

DISEASE CHARACTERISTICS:

- Samples available from patients previously enrolled in one of the following
terminated National Cancer Institute-Institutional Review Board clinical trials:

Name

Location

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